Embodiments of the invention relate generally to a fluid-based heating and cooling system, and more particularly, to a system including compliant, fluid-filled sealed vessels for heating and cooling biological samples and other articles.
Cultured cells have emerged as a critical tool in biotechnology and biomedicine research and cell therapy. An unprecedented increase in the demand for cultured cell products is now driven by growth in biopharmaceuticals, cancer research, cell and gene therapy, and stem cell research. The integration of cells cultured in multi-well formats (typically 96- to 384-wells), cell function specific fluorescent probes, laser scanning fluorescent (plus UV and visible light) plate readers, and supporting robotics has created a powerful tool in cultured cell products in support of research in biopharmaceuticals (drug discovery), vaccine development, stem cell research, cell and gene therapy, toxicological testing, cosmetics, bio-defense, diagnostic healthcare, environmental monitoring, and basic sciences research.
In order to facilitate production, on-hand inventory for on-demand use, and subsequent distribution of cell- and tissue-based products for therapeutic, research, and consumer-based use, product freezing (cryopreservation) has emerged as a necessary and critical part of the process. To this end, numerous protocols, devices, solutions, and thousands of studies have been published on better ways to freeze biologics.
As with freezing, the thawing process has a critical impact on product quality and downstream utility. Warm (37° C.) water baths have been used in the cell therapy and research communities to thaw samples in various container formats, including vials, straws, bags, syringes, ampules, dishes and culture plates. Although warm water baths provide rapid and effective thawing of samples, there are a number of challenges associated with the process including but not limited to sterility, consistency, controllability, documentation and cleanliness. Dry thawing systems have also been used, but only in limited applications such as, e.g., blood banking, and thawing of blood component and plasma products frozen in bags to the exclusion of other container formats. Such systems are limited in compatible container formats, the thermal profiles that can be generated, and other parameters.
In the consumer market, a similar void exists for a warming device for a variety of applications, including but not limited to rapid thawing of frozen food, or as a therapeutic device to soothe and treat muscular and soft tissue injuries.
Accordingly, there is a need for a device and method to allow for controlled, multi-sample, high volume, reproducible, rapid warming or thawing of samples including, e.g., cells, tissues, DNA, proteins and antibodies, vaccines, and viruses, that are compatible with research, clinical, and consumer settings.